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Simplify Medical Raises $21M

The company is developing an MRI-compatible artificial cervical disc.

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Smith & Nephew Announces Knee Surgery Research Project

SNN will partner with Imperial College London to develop new surgical techniques.

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Simplify Medical Raises $21M

Simplify Medical announced the closing of a $21 million Series B round of financing. The round was led by LSP (Life Sciences Partners), who were joined by Sectoral Asset Management and returning investor M.H. Carnegie. Funds will be used to support two ongoing U.S. pivotal clinical trials of the Simplify artificial cervical disc. The studies are currently enrolling patients with cervical degenerative disc disease to undergo treatment at one level and two adjacent levels of the spine.

The Simplify disc is unique because it is constructed from PEEK endplates and a ceramic composite core, so there is no risk of metal wear. Further, metal artifact from artificial discs with metal components can make the spine challenging to evaluate on MRI after surgery, meaning patients would require CT and thus be exposed to ionizing radiation. The materials used in the Simplify disc are MRI-compatible.

The Simplify disc has received the CE Mark, and the company notes that the device has been used to treat more than 700 patients outside the U.S. over the last three years. Simplify has not announced when they expect to receive FDA approval for the device.


Posted July 25, 2017

Smith & Nephew Announces Knee Surgery Research Project

Smith & Nephew announced last week a partnership with Imperial College London to develop “enhanced surgical techniques” to address ligament function, biomechanics and soft tissue injuries of the knee. The project, which is funded by a three-year, $1 million grant from Smith & Nephew, aims to improve treatment for common knee injuries, such as torn menisci and anterior cruciate ligaments. The company announced a similar effort at the University of Hull in July, where GBP 3 million (approximately $4.0 million) in funding will be used to develop novel treatments in wound care.


Posted September 12, 2017
TELA Bio Raises Up to $25M

TELA's scaffolds are used for hernia repair and abdominal wall reconstruction.

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Amgen Invests in Fortuna Fix

It's the company's first investment in the regenerative medicine space.

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TELA Bio Raises Up to $25M

TELA Bio announced that Pacira Pharmaceuticals, Inc. will invest up to $25 million in the company, with $15 million provided up front and up to an additional $10 million upon fulfillment of certain milestones. TELA Bio, which is led by former Orthovita CEO Antony Koblish, has developed the OviTex line of soft tissue scaffolds, which are manufactured in a range of sizes and thicknesses as well as in permanent and resorbable formulations. This enables multiple configurations to address a variety of hernia repair and abdominal wall reconstruction needs. Notably, the company says the scaffolds feature a unique design that combines “biologic and synthetic materials in a unique embroidered construction that allows free movement of fluid and cells through the construct.”

The company will use funds from the Pacira financing to expand clinical and commercial efforts for their existing products and indications as well as  develop new OviTex products for additional soft tissue procedures, including breast reconstruction.


Posted November 02, 2017

Amgen Invests in Fortuna Fix

Amgen is participating in a $25 million Series B round for Fortuna Fix, a regenerative medicine company based in Canada that is developing an autologous neural stem cell treatment for the replacement of lost neuronal tissue. The treatment is clinical-stage and uses direct reprogramming of somatic cells into neural precursor cells, which can be further optimized for specific indications. The technology uses no fetal or embryonic cells (i.e., pluripotent cells, which have been associated with safety issues, including development of tetromas) and no animal, viral or bacterial components. Further, the cells, called drNPCs, are believed to be safe to deliver without immunosuppression.

Funds will be used to conduct Phase I/IIa clinical trials in Parkinson’s Disease and Spinal Cord Injury, as well as to expand Fortuna’s automated robotic manufacturing capabilities. FierceBiotech reports that when the cell therapy will be ready for human testing and the exact patient populations where the treatment will be evaluated have not been determined, but the company is in discussions with clinical advisors and the FDA to further those decisions.


Posted November 14, 2017